Director of Regulatory Affairs
4 weeks ago
At GSK, we are seeking a highly skilled and experienced Director of Regulatory Affairs to join our team. As a key member of our Global Regulatory Affairs organization, you will play a critical role in ensuring the regulatory compliance of our biopharmaceutical products.
Key Responsibilities- Lead CMC regulatory activities for investigational and/or early commercial biopharmaceuticals, ensuring timely preparation and submission of regulatory documents.
- Develop and execute CMC regulatory strategies to support major inspections and quality incidents, ensuring compliance with regulatory requirements.
- Collaborate with cross-functional teams to ensure alignment on regulatory strategies and ensure effective communication of regulatory risks and mitigation strategies.
- Provide regulatory guidance and support to in-licensing and divestment projects, ensuring compliance with regulatory requirements.
- Develop and maintain relationships with regulatory agencies, ensuring effective communication and collaboration on regulatory matters.
- Bachelor's degree in a biological sciences area.
- 7+ years of direct CMC regulatory experience, with a focus on biopharmaceuticals.
- Experience leading key, strategic CMC regulatory activities for investigational and/or early commercial biopharmaceuticals.
- Experience working in a large enterprise company, leading complex projects and collaborating with cross-functional teams.
- Experience working with new drug applications in the US or EU.
- Advanced degree in a biological sciences area.
- 5+ years of CMC regulatory project leadership experience with biological medicines, including therapeutic proteins and/or cell & gene therapies.
- Ability to demonstrate flexible thinking and high resilience in the workplace.
- Ability to work with frequent changing priorities within a fast-paced work culture.
Why GSK?
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive.
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